Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Phase 2

Terminated

• Conditions: PTSD
• Interventions: Drug: SRX246; Drug: Placebo

• Registration Number: NCT02733614
• Lead Sponsor: Azevan Pharmaceuticals

Brief Summary

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Study Start: 2016-12
• Primary Completion: 2020-10
• Study Completion: 2021-03-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Medically stable, current diagnosis of PTSD

Exclusion Criteria

• Medically unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SRX246	SRX246	SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks
Placebo	Placebo	oral administration, capsules, daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Assessment of overall clinical improvement	18 weeks	Measured using the Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	18 weeks	Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
Reduction in depressive symptoms	18 weeks	Measured using the Beck Depression Inventory (BDI)
Reduction in anger and aggression	18 weeks	Measured using the Overt Aggression Scale-Modified (OAS-M)
Reduction in irritability	18 weeks	Measured using the Sheehan Irritability Scale (SIS)
Improvement in overall functioning	18 weeks	Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
Improvement in quality of life	18 weeks	Measured using the Sheehan Disability Scale (SDS)
Improvement in sleep quality	18 weeks	Measured using the Pittsburgh Sleep Quality Index (PSQI)

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States